Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Glaucoma is the second leading cause of blindness and the first leading cause of irreversible vision loss worldwide. The intraocular pressure (IOP) is the only modifiable risk factor for all the spectrum of glaucoma. Reducing IOP in glaucoma increases the likelihood of preventing progression of the disease and preserving the quality of life of the patient. Although prostaglandin analogs (PGAs) and prostamides (PMs) are de facto first-line treatment options for managing glaucoma, it is a common clinical experience to see their treatment effects plateau to a level beyond which no clinically significant IOP reduction is likely. It is also common to find minimal IOP treatment effects in the following conditions: patients with normal tension glaucoma (NTG), patients with thicker central corneal thickness (CCT), and patients with higher levels of corneal hysteresis (CH). CH is a possible proxy for the ability of the scleral tissue around the optic nerve to dissipate energy away from the optic nerve fibers. Netarsudil, a rho-kinase inhibitor was recently approved by the FDA for the treatment of glaucoma and ocular hypertension. There is a paucity of research on the efficacy of netarsudil in patients with NTG, thicker CCT, and higher levels of CH. This study aims to investigate the above issues by evaluating the efficacy of netarsudil and bimatoprost in subjects with NTG, thicker corneas, and higher levels of CH.

Hypotheses

• Netarsudil will have non-inferior efficacy compared to Bimatoprost in treating NTG.

• Corneal thickness and corneal hysteresis will reduce the efficacy of netarsudil similar to bimatoprost in NTG.

• Netarsudil will change corneal thickness and corneal hysteresis similar to bimatoprost in NTG.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salus University
• Treatments: Bimatoprost

Criteria

-Inclusion Criteria:

• New NTG patients naïve to treatment.

• Patient with 360 degrees open angles on gonioscopy.

• Patients with glaucomatous optic neuropathies (GON).

• Patients with three repeatable visual field defects over two visits.

• Subjects must have IOPs ≤ 21 mmHg and no recorded IOPs > 21 mmHg at any time.

Glaucomatous optic neuropathy and visual field criteria:

Category 1 and 2 of the glaucoma diagnostic criteria of the International Society of Geographical and Epidemiological Ophthalmology (ISGEO) will be adopted in this study.

ISGEO Category 1 classification of glaucoma:

Reliable and repeatable visual field defects consistent with a glaucomatous optic neuropathy, and either a vertical cup-disc ratio (VCDR) at the 97.5th percentile of the normal population (about 0.7 VCDR), or VCDR asymmetry between the right and left eyes at the 97.5th percentile of the normal population (i.e., about 0.2).

ISGEO Category 2 classification of glaucoma:

Visual field results are not definitive or are unattainable due to patient inability to perform an adequate quality test, and optic disc has VCDR of at the 99.5th percentile of the normal population (i.e., VCDR of about 0.9) or VCDR asymmetry between the right and left eyes at the 99.5th percentile of the normal population (i.e a CDR asymmetry of about 0.3).

-Exclusion Criteria

• Patients with IOPs greater than 21 mmHg at any previous point in time

• Patients with corneal pathology

• Previous ocular surgery in the past 6 months

• Patients with any other types of glaucoma other than NTG

• Patients who are unwilling or unable to follow-up for a 3-month period

• Patients with systemic conditions where a non-glaucomatous optic neuropathy cannot be ruled out.

• Subjects who are pregnant, breastfeeding, or considering becoming pregnant

• Subjects who could be pregnant will be screened for pregnancy thus: Those who are not pregnant nor considering becoming pregnant and are not on any birth-control at the time of recruitment will be excluded from participation because of the risk of pregnancy unknown to the patient at the time of recruitment.